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1、BRITISH STANDARD BS EN ISO 14408:2005 Tracheal tubes designed for laser surgery Requirements for marking and accompanying information The European Standard EN ISO 14408:2005 has the status of a British Standard ICS 11.040.10 ? Licensed Copy: London South Bank University, London South Bank University
2、, Tue Jan 30 01:18:51 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS EN ISO 14408:2005 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 January 2007 BSI 2007 ISBN 978 0 580 50128 9 National foreword This British Standard was published by BSI
3、. It is the UK implementation of EN ISO 14408:2005. It supersedes BS ISO 14408:1998 which is withdrawn. The UK participation in its preparation was entrusted by Technical Committee CH/121, Anaesthetic and respiratory equipment, to Subcommittee CH/121/2, Tracheal tubes and related equipment. A list o
4、f organizations represented on CH/121/2 can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obliga
5、tions. Amendments issued since publication Amd. No. DateComments Licensed Copy: London South Bank University, London South Bank University, Tue Jan 30 01:18:51 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14408 June 2005 ICS 11.040.10 English ve
6、rsion Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2005) Tubes trachaux destins aux oprations laser - Exigences relatives au marquage et aux informations daccompagnement (ISO 14408:2005) Trachealtuben fr die Laserchirurgie - Anforderung
7、en an die Kennziechnung und die begleitenden Informationen (ISO 14408:2005) This European Standard was approved by CEN on 12 May 2005. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national s
8、tandard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any othe
9、r language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, Fr
10、ance, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUN
11、G Management Centre: rue de Stassart, 36 B-1050 Brussels 2005 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 14408:2005: E Licensed Copy: London South Bank University, London South Bank University, Tue Jan 30 01:18:51 GMT+00:00
12、 2007, Uncontrolled Copy, (c) BSI Foreword This document (EN ISO 14408:2005) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment“ in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment“, the secretariat of which is held by B
13、SI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by December 2005, and conflicting national standards shall be withdrawn at the latest by December 2005. This document has been prepared under a man
14、date given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations
15、, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
16、Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 14408:2005 has been approved by CEN as EN ISO 14408:2005 without any modifications. EN ISO 14408:2005 Licensed Copy: London South Bank University, London South Bank University, Tue
17、 Jan 30 01:18:51 GMT+00:00 2007, Uncontrolled Copy, (c) BSI Reference number ISO 14408:2005(E) INTERNATIONAL STANDARD ISO 14408 Second edition 2005-06-01 Tracheal tubes designed for laser surgery Requirements for marking and accompanying information Tubes trachaux destins aux oprations laser Exigenc
18、es relatives au marquage et aux informations daccompagnement EN ISO 14408:2005 Licensed Copy: London South Bank University, London South Bank University, Tue Jan 30 01:18:51 GMT+00:00 2007, Uncontrolled Copy, (c) BSI ii Licensed Copy: London South Bank University, London South Bank University, Tue J
19、an 30 01:18:51 GMT+00:00 2007, Uncontrolled Copy, (c) BSI iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical comm
20、ittees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
21、International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft Internation
22、al Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be th
23、e subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 14408 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 2, Tracheal tubes and other equipment. This second edition cancels and replace
24、s the first edition (ISO 14408:1998), Clauses 4 and 5 and Figure 1 of which have been technically revised. For the purposes of this International Standard, the CEN annex regarding fulfilment of European Council Directives has been removed. EN ISO 14408:2005 Licensed Copy: London South Bank Universit
25、y, London South Bank University, Tue Jan 30 01:18:51 GMT+00:00 2007, Uncontrolled Copy, (c) BSI iv Introduction This International Standard is intended to provide requirements for marking, labelling and information supplied for tracheal tubes which are designed for resistance to ignition by a laser
26、and which have been tested for laser resistance in accordance with ISO 11990 including a standard format for reporting results obtained when tested in accordance with ISO 11990. It is intended that, by limiting the requirements to disclosure of information determined in accordance with standard test
27、 methods, the manufacturer will be allowed maximum use of alternatives in design and materials. EN ISO 14408:2005 Licensed Copy: London South Bank University, London South Bank University, Tue Jan 30 01:18:51 GMT+00:00 2007, Uncontrolled Copy, (c) BSI 1 Tracheal tubes designed for laser surgery Requ
28、irements for marking and accompanying information 1 Scope This International Standard specifies marking, labelling and information to be supplied by the manufacturer for cuffed and uncuffed tracheal tubes and related materials designed to resist ignition by a laser. 2 Normative references The follow
29、ing referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 11990, Optics and optical instruments Lasers and laser-
30、related equipment Determination of laser resistance of tracheal tube shafts 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 tracheal tube tube designed for insertion through the larynx into the trachea to convey gases and vapours to and from
31、the trachea ISO 4135:2001 3.2 cuff inflatable balloon permanently attached around the tracheal tube near the patient end to provide an effective seal between the tube and the trachea NOTE Adapted from ISO 4135:2001. 3.3 laser-resistant tracheal tube tracheal tube specifically designed by the manufac
32、turer for use during laser surgery of the airway NOTE This includes devices sold preassembled or in kit form. 3.4 laser-resistant tracheal tube treatment covering and/or surface treatment that adapts or modifies non-laser-resistant tracheal tubes for use in laser surgery of the airway EN ISO 14408:2
33、005 Licensed Copy: London South Bank University, London South Bank University, Tue Jan 30 01:18:51 GMT+00:00 2007, Uncontrolled Copy, (c) BSI 2 3.5 upper anatomical airway upper airway airway above the laryngotracheal junction 3.6 laser-resistant portion that portion of the tracheal tube intended by
34、 the manufacturer to be laser-resistant 4 Marking and labelling 4.1 Use of symbols The requirements given in 4.2, 4.3, and 4.4 may be met by the use of the appropriate symbols in accordance with ISO 7000 or EN 980. 4.2 Marking 4.2.1 Marking of tracheal tubes, connectors, packages, inserts and inform
35、ation to be supplied by the manufacturer should comply with EN 1041. 4.2.2 The following shall be permanently marked on or affixed to the tracheal tube or tracheal tube treatment: a) the name and/or trademark of the manufacturer or supplier; b) the nominal inside diameter in millimetres designated b
36、y the manufacturer for the tracheal tube; c) model identification, if necessary to distinguish between similar products from the same manufacturer; d) for cuffed tracheal tubes, a reference to any preparation designated by the manufacturer as essential for protection of the cuff from ignition (e.g.
37、“inflate the cuff with saline or water before use”). 4.2.3 Additional marks may be provided (optional) to assist in positioning the tracheal tube within the trachea. 4.2.4 Any component of a laser-resistant tracheal tube treatment that is affixed to, or protects the treatment covering or material un
38、til it is applied to the tracheal tube, shall be marked with a reference to any preparatory steps designated by the manufacturer as essential to the laser resistance of the tube (e.g. “saturate covering with saline solution”). 4.2.5 If the laser-resistant portion is not visually obvious, this shall
39、be marked. 4.2.6 If any marks are applied to the laser-resistant area of the tracheal tube, the test to determine laser-resistance values required for the graph in 5.4 shall be carried out directly upon these markings. 4.2.7 All markings shall be of sufficient size and contrast to be legible. 4.2.8
40、All markings shall be non-toxic and tissue-compatible. Marking materials should resist deterioration by anaesthetic agents. The markings should be durable and remain legible during use of the tube. If the tracheal tube is intended for reuse, the materials should resist deterioration by the recommend
41、ed agents and procedures used to clean and disinfect or sterilize the device. EN ISO 14408:2005 Licensed Copy: London South Bank University, London South Bank University, Tue Jan 30 01:18:51 GMT+00:00 2007, Uncontrolled Copy, (c) BSI 3 4.3 Labelling of packs The following information shall be on the
42、 laser-resistant tracheal tube or laser-resistant tracheal tube treatment pack: a) a description of contents, including wording to indicate that the tracheal tube is intended for use in laser surgery; b) the name and/or trademark of the manufacturer or supplier; c) the product code or catalogue numb
43、er; d) the largest outside diameter after preparations for use; e) the nominal internal diameter in millimetres designated by the manufacturer for the tracheal tube; f) the means to ensure traceability such as type, batch or serial number or year of manufacturer; g) the word “STERILE” or “NON-STERIL
44、E”, as appropriate; h) for tracheal tubes not intended for reuse, the words “SINGLE USE” or equivalent; i) for cuffed tracheal tubes, the cuff resting diameter, expressed in millimetres; j) any storage instructions, including a statement of known conditions of storage likely to result in rapid deter
45、ioration of the materials (e.g. high temperature, ultraviolet light or fluorescent lighting); k) the “use by” date expressed as (YYYY-MM); l) an instruction to refer to information describing laser resistance, including type(s) and nominal wavelength(s), considered by the manufacturer as appropriate
46、 for use and contraindications. 4.4 Labelling of shelf or multi-unit containers The following information shall be on shelf or multi-unit containers: a) the descriptive name of the device (trademark, etc.); b) the name and/or trademark of the manufacturer or supplier; c) the product code or catalogu
47、e number; d) the nominal outside diameter of the tube; e) the nominal inside diameter of the tube; f) the batch number; g) the word(s) “STERILE” or “NON-STERILE”, as appropriate; h) for tracheal tubes not intended for reuse, the words “SINGLE USE” or equivalent; i) the “use by” date expressed as (YY
48、YY-MM); j) the quantity of unit packages in the container; k) any storage instructions, including a statement of known conditions of storage likely to result in rapid deterioration of the materials (e.g. ultraviolet light or fluorescent lighting); l) an instruction to refer to information describing
49、 laser resistance, including type(s) and nominal wavelength(s) considered by the manufacturer as appropriate for use and contraindications. EN ISO 14408:2005 Licensed Copy: London South Bank University, London South Bank University, Tue Jan 30 01:18:51 GMT+00:00 2007, Uncontrolled Copy, (c) BSI 4 5 Information to be supplied by the manufacturer 5.1 Instructions for preparation and use of laser-resistant tracheal tube and tracheal tube treatments 5.1.1 For laser-resistant tracheal tube treat